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Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa

RecruitingPhase 4Ages 18 Years - anyAllNovartis Pharmaceuticals
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In plain words

What the trial is, and whether it could suit you

This is a post-approval commitment study to evaluate efficacy, and safety of two dosing regimens of secukinumab (AIN457), 300 mg every four weeks (Q4W) and every two weeks (Q2W), in Chinese adult patients with moderate to severe hidradenitis suppurativa (HS).

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Signed informed consent must be obtained before any assessment is performed. * Chinese male and female participants ≥ 18 years of age. * Confirmed/documented diagnosis of HS ≥ 6 months prior to baseline. * Participants with moderate to severe HS at baseline defined as: * A total of at least 5 inflammatory lesions, i.e., abscesses and/or inflammatory nodules AND * Inflammatory lesions should affect at least 2 distinct anatomic areas (e.g., left and right axillae) Exclusion Criteria: * Total fistulae count ≥ 20 at baseline. * Any other active skin disease or condition that may interfere with assessment of HS at baseline. * Active inflammatory bowel disease. * Underlying conditions (including, but not limited to, metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious including tuberculosis and hepatitis, or gastrointestinal conditions), which in the opinion of the investigator, significantly immunocompromise the participant and/or place the participant at unacceptable risk for receiving an immunomodulatory therapy. * Use or planned use of systemic biological/non-biological immunomodulator, corticosteroid treatment for HS, or participation in any interventional trial * Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17A, IL-17 A/F or the IL-17 receptor. * Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using methods of contraception during the entire study.
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What it tests

  • Secukinumab
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Where

10 sites
Novartis Investigative Site
Guangzhou, China
Novartis Investigative Site
Shijiazhuang, China
Novartis Investigative Site
Chengdu, China
Novartis Investigative Site
Hangzhou, China
Novartis Investigative Site
Ningbo, China
Novartis Investigative Site
Wenzhou, China
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Beijing, China

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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